MULTIVARIATE ANALYSIS OF PFS FROM THE AETHERA TRIAL: A PHASE 3 STUDY OF BRENTUXIMAB VEDOTIN CONSOLIDATION AFTER AUTOLOGOUS STEM CELL TRANSPLANT FOR HL
Author(s): ,
Jan Walewski
Affiliations:
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie,Warsaw,Poland
,
Auayporn Nademanee
Affiliations:
City of Hope National Medical Center,Duarte,United States
,
Tamas Masszi
Affiliations:
Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly,Budapest,Hungary
,
Jerzy Holowiecki
Affiliations:
Oddzial Transplantacji Szpiku Centrum Onkologii- Instytut M. Sklodowskiej-Curie, Oddzial Gliwicach,Gliwice,Poland
,
Muneer Abidi
Affiliations:
Karmanos Cancer Institute / Wayne State University,Detroit,United States
,
Andy Chen
Affiliations:
Oregon Health and Science University / Center for Hematologic Malignancies,Portland,United States
,
Patrick Stiff
Affiliations:
Loyola University Medical Center,Maywood,United States
,
Simonetta Viviani
Affiliations:
Istituto Nazionale dei Tumori,Milano,Italy
,
Veronika Bachanova
Affiliations:
University of Minnesota,Minneapolis,United States
,
John Sweetenham
Affiliations:
The Cleveland Clinic,Cleveland,United States
,
Shih-Yuan Lee
Affiliations:
Takeda Pharmaceuticals International Company,Cambridge,United States
,
Dirk Huebner
Affiliations:
Takeda Pharmaceuticals International Company,Cambridge,United States
,
Emily Larsen
Affiliations:
Seattle Genetics, Inc.,Bothell,United States
,
Naomi Hunder
Affiliations:
Seattle Genetics, Inc.,Bothell,United States
Craig H. Moskowitz
Affiliations:
Memorial Sloan-Kettering Cancer Center,New York,United States
EHA Learning Center. Walewski J. Jun 14, 2015; 103064
Disclosure(s): Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
Jan Walewski
Jan Walewski

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Abstract: S807

Type: Oral Presentation

Presentation during EHA20: From 14.06.2015 08:30 to 14.06.2015 08:45

Location: Room Lehar 3 + 4

Background

In the phase 3, randomized, placebo-controlled AETHERA trial, progression-free survival (PFS) was significantly improved with brentuximab vedotin (BV) vs placebo (HR=0·57, P=0·001) in Hodgkin lymphoma (HL) patients at risk of progression post-autologous stem cell transplant (ASCT). 



Aims

A multivariate analysis was performed to determine which factors significantly influence PFS by investigator assessment.



Methods

After ASCT, 329 patients were randomized to receive BV 1.8 mg/kg q3wk (n=165) or placebo (n=164) for up to 16 cycles. The primary endpoint was PFS per independent review. Multivariate analysis using a Cox-proportional hazards model was developed on the following factors: treatment, age, sex, weight, geographical region, initial disease stage, time from diagnosis, no. of treatments pre-ASCT, chemosensitivity, response to frontline (FL) and salvage, type of FL therapy, prior radiotherapy, extranodal disease pre-ASCT, ASCT conditioning regimen, B symptoms at pre-ASCT relapse, number of risk factors, baseline ECOG, baseline lesions, and pre-existing peripheral neuropathy.

Significant factors (p<0.05) were determined after a stepwise addition and elimination of nonsignificant factors from the model. 



Results

Multivariate modeling indicated that factors significantly associated with PFS by investigator assessment included: treatment (BV vs. placebo), salvage response, gender, number of treatments pre-ASCT, type of FL therapy, B symptoms pre-ASCT, and weight (see Table). 



Summary

After adjustment for significant clinical factors in a multivariate regression analysis, consolidation treatment with BV significantly reduced the risk of treatment failure compared to placebo with a HR of 0.44. These results support the primary analysis.



Keyword(s): Autologous hematopoietic stem cell transplantation, Hodgkin's lymphoma



Session topic: Progess in Hodgkin lymphoma therapy: Incorporation of novel agents and reduction of side effects
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